Icotrokinra Hydrochloride: package leaflet

What ICOTYDE is
ICOTYDE contains the active substance icotrokinra.

This medicine helps to control the inflammation associated with psoriasis by blocking a protein called IL-23R, which is increased in people with psoriasis.

ICOTYDE is used to treat moderate-to-severe plaque psoriasis (a disease causing red, scaly patches on the skin). It is used in adults, and adolescents aged 12 years and older with a body weight of at least 40 kg.

ICOTYDE can improve the condition of the skin and appearance of nails. ICOTYDE can reduce signs such as scaling, redness and skin thickness and improve symptoms such as itching, pain, stinging, burning and skin tightness. ICOTYDE can also improve the quality of life in patients with psoriasis.

Do not take ICOTYDE
− if you are allergic to icotrokinra or any of the other ingredients of this medicine (listed in section 6).
− if you have an active infection, including active tuberculosis, which your doctor thinks is important.

Warnings and precautions
Talk to your doctor or pharmacist before and during the use of ICOTYDE:
− if you have recently received or are scheduled to receive an immunisation (vaccine):

- you should avoid receiving live vaccines during treatment with ICOTYDE and within 3 days after stopping treatment with ICOTYDE.
− if you currently have an infection, a long-term infection, or if you have an infection that keeps coming back.

Children and adolescents
ICOTYDE is not recommended for children and adolescents under 12 years of age or with a body weight below 40 kg because it has not been studied in this group.

Other medicines and ICOTYDE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the unborn baby.

If you took ICOTYDE when you were pregnant:
− tell your baby’s doctor and other health care professionals before your baby has any vaccines.
− live vaccines are not recommended for your baby in the first 3 days after birth unless your baby’s doctor recommends otherwise.

It is unknown whether ICOTYDE passes into human breast milk. Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor should decide if you will breast-feed or use ICOTYDE.

Driving and using machines
ICOTYDE is unlikely to influence your ability to drive and use machines.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

ICOTYDE is available as a tablet which is taken by mouth.
The recommended dose is 200 mg every day.
−
Take on an empty stomach after you wake up.
−
Swallow the tablet whole with water.
−
After taking the ICOTYDE tablet, wait at least 30 minutes before eating food.

If you have trouble swallowing whole tablets
−
Place one tablet in a cup with at least 120 mL of water.
−
Wait a few minutes until the tablet breaks up and spreads out. The mixture may look yellow, milky, or cloudy. Small pieces may be seen in the water – these are safe to swallow.
−
Swirl the mixture in the cup before drinking and swallow the full mixture straight away.
−
Fill the cup with at least another 120 mL of water and drink straight away to make sure that you take the full dose.

If you take more ICOTYDE than you should
If you take more ICOTYDE than you should, talk to your doctor straight away.

If you forget to take ICOTYDE
If you forget to take a dose, take the missed dose on the same day as soon as possible. Take your next dose at the usual time on the next day.

Do not take a double dose to make up for a forgotten dose.

If you stop taking ICOTYDE
Do not stop using this medicine without talking to your doctor. If you stop treatment, symptoms of psoriasis may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor, pharmacist or nurse if you get any of the following side effects

Common (may affect up to 1 in 10 people)

− fungal infection

Uncommon (may affect up to 1 in 100 people)

− inflamed lower part of the gut (diverticulitis)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister, bottle and carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.

Blister: Store in the original package in order to protect from moisture.

Bottle: Store in the original package and keep the bottle tightly closed in order to protect from moisture.

Do not use this medicine if you notice the tablets are damaged or there are signs of tampering with the medicine packaging.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What ICOTYDE contains
−
The active substance is icotrokinra. Each film-coated tablet contains 200 mg of icotrokinra.
−
The other ingredients are:

• Tablet core: colloidal anhydrous silica (E551), crospovidone (E1202), magnesium stearate (E572), silicified microcrystalline cellulose.
• Film-coating: macrogol polyvinyl alcohol graft copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (E471), polyvinyl alcohol partially hydrolysed (E1203) and iron oxide yellow (E172).

What ICOTYDE looks like and contents of the pack

ICOTYDE is a yellowish orange to yellowish brown, oval film-coated tablet (tablet) approximately 19 mm in length and 9 mm in width debossed with ‘200’ on one side and ‘JNJ’ on the other side.

The tablets may be supplied either in a bottle or in a blister pack.

Blister
ICOTYDE 200 mg film-coated tablets are available in the following packs:
−
Unit packs containing 7 x 1film-coated tablets in 1 aluminum perforated unit dose blister card OR − Unit packs containing 28 x 1 film-coated tablets in 4 aluminum perforated unit dose blister cards of 7 tablets each OR − Multipacks containing 84 (3 packs of 28 x 1) film-coated tablets

Bottle
The film-coated tablets are supplied in a plastic bottle with a child-resistant closure. Each bottle contains 30 film-coated tablets and a desiccant. Each carton contains one bottle. Do not swallow or remove the desiccant.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Cilag SpA
Via C. Janssen
Borgo San Michele
04100 Latina
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: 0800 93 377 info_belux@its.jnj.com

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88 lt@its.jnj.com

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00 jjsafety@its.jnj.com

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: 800 29 504 info_belux@its.jnj.com

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858 janssenhu@its.jnj.com

Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282 jacdk@its.jnj.com

Malta
AM MANGION LTD
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955 medinfo-de@its.jnj.com

Nederland
Janssen-Cilag B.V.
Tel: 0800 242 42 42 info_nl@its.jnj.com

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410 ee@its.jnj.com

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00 jacno@its.jnj.com

Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00 contacto@its.jnj.com

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 medisource@its.jnj.com

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122 medinfo@its.jnj.com

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
JNJ-SI-safety@its.jnj.com

Ísland
Janssen-Cilag AB c/o Vistor ehf.
Sími: +354 535 7000 janssen@vistor.is

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300 jacfi@its.jnj.com

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00 jacse@its.jnj.com

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561 lv@its.jnj.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu